N/A
Completed N=20
Comparison of One-port and Two-port Tissue Expanders for Breast Reconstruction
Source: ClinicalTrials.gov NCT02725801 ↗Enrolled (actual)
20
Serious AEs
25.0%
Results posted
Sep 2020
Primary outcomePrimary: Number of Participants With Successful Replacement of Tissue Expander With Permanent Implant — 8; 12 Participants
Summary
Appropriate patients undergoing going immediate breast reconstruction with tissue expanders following mastectomy will be randomized to receive one-port or two-ports tissue expanders. Their clinical course, complications, and outcome will be analyzed.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Successful Replacement of Tissue Expander With Permanent Implant |
8; 12 | — |
| SECONDARY Number of Participants Who Required Additional Intervention |
1; 4 | — |
Eligibility Criteria
Inclusion Criteria
- patient agrees to immediate tissue expander breast reconstruction
- a suitable patient for tissue expander reconstruction
Exclusion Criteria
- not a surgical candidate for immediate breast reconstruction
- age less than 18
- patient declines tissue expander reconstruction
- patient anticipated to need radiation therapy postoperatively
Data sourced from ClinicalTrials.gov (NCT02725801). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.